Mild cognitive impairment (MCI) Mental and Behavioural Disorders
Conditions
Interventions
An external department will create randomization lists (Institute of Medical Informatics, Biometry, and Epidemiology, Friedrich-Alexander University Erlangen-Nürnberg, Waldstraße 6, 91054 Erlangen).
Sponsors
Karl und Veronica Carstens-Stiftung
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 24/11/2021: 1. Mild cognitive impairment: 1.1. Montreal Cognitive Assessment score =24 1.2. Mini Mental State Examination score =24 2. The digital applications and examinations require a PC with a microphone and camera (Windows/Linux/MacOS), laptop or an Android tablet and basic skills in their use and access to the internet 3. Age =60 years 4. Informed consent given Previous inclusion criteria: 1. Mild cognitive impairment: 1.1. Montreal Cognitive Assessment score =24 1.2. Mini Mental State Examination score =24 2. No depression (Patient Health Questionnaire [PHQ]-9 <12) 3. The digital applications and examinations require a PC with a microphone and camera (Windows/Linux/MacOS), laptop or an Android tablet and basic skills in their use 4. Age =60 years 5. Informed consent given 6. Subjective impairment of short-term memory
Exclusion criteria
Exclusion criteria: 1. Completely blind or deaf 2. No personal computer, laptop or tablet 3. Normal cognition, Montreal Cognitive Assessment score >24 4. Dementia, Mini Mental Status Examination score <24 5. Depression, Patient Health Questionnaire 9 score =12 6. Diagnosis of another disease that causes cognitive impairment: 6.1. Psychosis (schizophrenia, mania, bipolar psychosis) 6.2. Parkinson's disease 6.3. Multiple sclerosis 6.4. Multiple strokes 6.5. Alcohol abuse/drug consumption (addiction) 6.6. Severe brain disease (tumor, injury, hydrocephalus) 6.7. Severe vitamin B deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 26/01/2024: 1. Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 and 12 months Previous primary outcome measures from 06/12/2021 to 26/01/2024: 1. Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 months 2. Cognition measured by the computerised cognitive test battery (ccTB) integrated in the digital software at baseline and after 6 and 12 months Original primary outcome measure: Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/01/2024: 1. Cognitive function measured by the Mini-Mental State Examination (MMSE) at baseline and after 6 and 12 months 2. Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software (cctb) at baseline and after 1, 2, 3, 4, 5 and 6 months 3. Depression measured by the Patient Health Questionnaire 9 (PHQ-9) at baseline and after 6 and 12 months 4. Activities of daily living measured by the Bayer Activities of Daily Living Scale (B-ADL) at baseline and after 6 and 12 months Previous secondary outcome measures from 06/12/2021 to 26/01/2024: 1. Cognitive function measured by the Mini-Mental State Examination (MMSE) at baseline and after 6 and 12 months 2. Depression measured by the Patient Health Questionnaire 9 (PHQ-9) at baseline and after 6 and 12 months 3. Activities of daily living measured by the Bayer Activities of Daily Living Scale (B-ADL) at baseline and after 6 and 12 months Previous secondary outcome measures from 24/11/2021 to 06/12/2021: 1. Cognition measured by the Mini-Mental Status Examination (MMSE) at baseline and after 6 and 12 months 2. Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software at baseline and after 1, 2, 3, 4, 5 and 6 months Original secondary outcome measures: Cognition measured by the Mini-Mental Status Examination (MMSE) at baseline and after 6 and 12 months to detect the conversion rate to dementia | — |
Countries
Germany
Outcome results
None listed